Diabetying & lifestyle as medicine programme for people with diabetes type II in primary care
* an implementation pilot

T2D is usually diagnosed in primary care by the general practitioner (GP) or
general practitioner assistant (GPA). When T2D is diagnosed the first advice is
to try to change lifestyle for three months mainly by increasing exercise and
eating healthier (Nederlandse Diabetes Federatie, 2015). However, primary care
professionals do not have the knowledge and time to give sufficient support,
and most patients fail. After the first three months, most T2D patients start
with medication which only effects consequences of T2D and not the cause.

A new approach with personalised lifestyle interventions that target metabolic,
physical and social aspects, as well as behaviour is necessary. Sustainable
lifestyle and behaviour changes are challenging (Venkat Narayan, 2016). This
requires a careful and versatile approach in which science, clinical practice
and the needs of T2D patients assemble (Van Ommen et al., 2018).
*Diabetyping & Lifestyle as Medicine* (DLAM) is a treatment programme for T2D
patients that is developed by TNO. Aim of the programme is to reverse and, if
possible, cure T2D using lifestyle. The treatment programme consists of a
combination of proven-effective interventions in healthcare and the living
environment of patients. The programme starts with an extensive *360 degree*
diagnosis to map the largest bottlenecks (physical- or mental health,
lifestyle, medication, financial situation, social environment) for an
individual. The 360-degree diagnosis also includes the *diabetyping*, or
subtyping of diabetes type 2. This consist of an Oral Glucose Tolerance Test
(OGTT), based on which it can be determined which organs are insulin resistant
and to what extent the pancreas can still produce insulin. This information is
used to generate personalized dietary and exercise interventions. TNO used the
OGTT, diabetes subtyping and similar lifestyle advices before in the P4
Hillegom pilot. The research protocol was approved by the METC Brabant
(NL48742.028.14).

The *profile wheel* developed by TNO can support GPA and patient in getting a
good overview of the patient and where most room for improvement is based on
the results from the complete 360-degree diagnosis, and can aid GPA and patient
in developing a personalized lifestyle action plan. The *profile wheel* is an
interactive, visual representation of the core components which are; body (e.g.
glucose, cholesterol, blood pressure and weight), Think & feel (e.g.
experienced health, stress, problems with T2D), behaviour (mainly lifestyle)
and environment (financial-, relational-, or housing problems). The advice is
recorded in goals on which the patient can work.

TNO aims to implement the DLAM-treatment programme in a primary care setting.
This is considered a crucial step in the realisation of lifestyle as medicine
and reversing T2D. This study is a pilot to assess the feasibility of
implementation of the DLAM-treatment programme in primary care.

After a successful first pilot in 2018/2019, an effectivity study will be
executed in 2020. Aim is to prove the added value of the treatment programme as
compared to regular care. On the longer term, the aim is to implement the
DLAM-treatment programme on a larger scale, with the ultimate goal to change
the T2D treatment from care to cure.

Primary objective
The primary objective is to assess the organizational and financial feasibility
of implementation of the DLAM-treatment programme for T2D patients in primary
care. This includes an observational cost-benefit analysis, informing primary
care healthcare providers, and assessing experiences and identifying
bottlenecks from both care giver and patient perspective.
As a part of this, we will determine:
1. the organizational and financial possibilities for integrating the
DAM-treatment programme in primary care.
2. how costs and benefits change for health insurers, healthcare providers in
primary care and diabetes patients as a result of the DLAM-treatment programme.

Secondary objectives:
The secondary objective is to determine to which extend the DLAM-treatment
programme contributes to improved health status in people with T2D diabetes,
based on improvements in OGTT response profiles, body weight and use of
medication which will be assessed descriptively.

This study will be designed as an exploratory implementation study regarding
the feasibility of the DLAM-Treatment programme in primary care. The healthcare
partnership Stevenshof (collaboration between healthcare center Stevenshof and
general practice Zaaijer, Zaaijer en Hensing) in Leiden will act as first
fieldlab for implementation.
The study has two phases, as the initial high time investment from the involved
GPA*s limits the number of participants that can start at once. Besides that, a
two-phase approach allows for elimination of possible start-up issues in the
treatment programme and implementation thereof during the first phase.
T2D patients at healthcare partnership Stevenshof that are on the verge of a
change in their treatment will be asked to participate in this study by their
GPA.
Based on the 360-degree diagnosis (questionnaires, health data, OGTT) and a
consult with the GPA in which the profile wheel is used, these participants
will receive personalised lifestyle advise. During this study (six months), the
participants will have regular consults with their GPA, dietitian and
optionally physiotherapist. Besides that, group consults will be organised for
all participants. The GPA, dietitian, GP and pharmacist will be present during
these group consults. After 3 and 6 months the 360 diagnosis and OGTT will be
repeated.

Study design cost-benefit analysis
We have chosen an observational study design through process evaluation and
estimates. For the process evaluation we analyse monitor-data and information
from observations and semi-structured interviews with professionals, patients
and the purchasers of the main health insurer in the region. The estimations
will be based on existing evidence on elements (Chen et al, 2015), effectivity
(Israel, 2018) and the costs and benefits (Business Case, TNO: Zeist, 2017) of
the DLAM-treatment programme. We have chosen this design because of the limited
number of participants, making a quantitative cost-effectiveness analysis
impossible. The proposed design is in line with the usual methods for economic
evaluation of health and social care programmes, as has been worked out in
various manuals (for instance Drummond et.al, 2005; Larsen & De Boer, 2011).
In this study the following seven steps are followed:
1. Problem analysis: outline of the problems or bottlenecks for which the
intervention is being deployed; in this case health and lifestyle problems
owing to T2D.
2. Definition situation intervention: an interpretation of design, purpose and
effectiveness of the DLAM-treatment programme based on the results of previous
or adjacent research findings.
3. Definition zero alternative: In this step a description is made of the most
likely situation if the DLAM-treatment programme is not applied. It is a
description of costs and benefits in euros of regular care for diabetes
patients based on Dutch health standards (NHG standaard diabetes; NDF Standard
of Care Diabetes) and available data of diabetes care within Stevenshof.
4. Determine time horizon: In this step we analyse within which time (years)
effects can be realized. For the DLAM-treatment programme, costs must first be
incurred before any benefits arise. In addition, there will be benefits in the
longer term because the patients* lifestyle is expected to change. The chosen
time horizon is crucial: if it is too near, important benefits are not included
in the analysis. If the time horizon is far away, the benefits become more
uncertain.
5. Determine costs: We collect information about the costs of the
DLAM-treatment programme from primary health care professionals within
Stevenshof and the provider of the OGTT. These costs will relate to time spent
by professionals and analysts, medication used, and facilities needed. We
compare an overview of the costs of the DLAM-treatment programme witch the
costs of the zero alternative.
6. Determine benefits: a draft of possible benefits of the DLAM-treatment
programme in euros is compiled with the available business case of TNO. Then we
test these possible benefits against Stevenhof*s practice setting based on
available monitoring data and interviews witch professionals and patients. We
compare an overview of the benefits of the DLAM-treatment programme with that
of the zero alternative.
7. Overview of costs and benefits: The costs and benefits of the DLAM-treatment
programme are brought together in an overview. A distinction is made between
the return of investment for the parties involved: the patients, the healthcare
providers and the health insurers. If necessary, we conduct sensitivity
analysis to clarify the consequences of certain assumptions by working out
bandwiths of costs and benefits of the DLAM-treatment programme.

The intervention of this study is the DLAM-approach for T2D patients. First the
*360 degree* diagnosis is performed based on health markers and questionnaires
to map the largest physical and/or mental bottlenecks for an individual. The
360-degree diagnosis also includes the *diabetyping*, or subtyping of diabetes
type 2. This consist of an Oral Glucose Tolerance Test (OGTT) that provides
insight in the organ function of an individual with type 2 diabetes. Based on
the OGTT six T2D subtypes can be distinguished (see figure below).
Furthermore, the *profile wheel* that provides an overview of the 360-degrees
diagnosis results can aid GPA and patient in developing a personalized
lifestyle action plan. Which dietary intervention is recommended to a T2D
patient is personalized based on their diabetes subtype. The possible dietary
interventions include a Mediterranean diet, a low carbohydrate diet, a low
calorie diet or intermittent fasting. All four dietary pattern plans have been
developed in close collaboration with the dietician at Stevenshof. The
dietician will support and coach all patients in adhering to their selected
dietary pattern.
Based on their diabetes subtype patients may also be recommended to increase
their physical activity. If this is the case, a physiotherapist will provide
the patient with a fitting exercise plan, based on their condition and
capabilities.
Using the *profile wheel* tool, the advice is further concretized and recorded
in goals on which the patient can work during the four months of this pilot.
Regular meetings between the relevant healthcare providers and the patients
will be planned and progress of the action plan will be discussed. Although
most of the consults and medical tests are part of regular care, these might
occur more often and in a different order.

The risks associated with participation can be considered negligible and the
burden can be considered minimal. There are no expected risks related to the
extra consults. All medical actions, including blood collection, will only be
performed by primary care professionals. There are no expected risks (nor
benefits) related to consuming the standardized glucose solution. A potential
risk is nausea after consumption of the glucose solution, bruises from the
blood withdrawal, and a small risk for hypo due to insulin overshoot in
response to the glucose solution. This latter risk is limited and can be
sufficiently dealt with by the presence of health care professionals during the
OGTT. They will monitor the participants sufficiently to enable a safe
execution of the OGTT. Participants will be asked how they feel and their
behaviour will be monitored (sweating, alertness).
Other potential risks are concern amongst participants due to increased insight
in their health status from the 360-degree diagnosis. However, the results from
the 360-degree diagnosis will be explained by the GPA, which can also comfort
the patients.
Besides the risks accompanied with regular diabetes care, blood collection and
performing an OGTT, no other risks or negative side effects are known or
expected for the study tools.
With respect to treatment the participating GPs remain medical responsible of
their own participating patients.

Benefits include that participants can get more insight in their individual
health status and their behaviour. Additionally, participants are provided with
more personalized lifestyle advice and professional support in adhering to this
advice; this can help patients improve their health status and potentially
reverse their T2D.